DEVICE: plasmatherm (04059201000018)

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Device Identifier (DI) Information

plasmatherm
US-TCP
212.10053
Barkey GmbH & Co. KG
04059201000018
GS1
1
Thawing and warming device for frozen Plasma (FFP, PF24, AHF), Whole Blood, RBC and IV solution
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Plasma thawing unit A mains electricity (AC-powered) device intended to be used to thaw, in a controlled manner, units of frozen plasma that have been stored, e.g., in the blood bank, prior to use. This device can use a number of methods to achieve this, e.g., microwave oven, heated water bath.
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FDA Product Code

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Product Code Product Code Name
KZL Device, Warming. Blood And Plasma
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Humidity: between 30 and 90 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 70 Degrees Celsius
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
October 13, 2016

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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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+12017081400
info@genesisbps.com
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